CLINICAL TRIALS PROFILE FOR COPAXONE

All Clinical Trials for Copaxone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00039988 ↗	Treatment of Multiple Sclerosis With Copaxone and Albuterol	Completed	Autoimmunity Centers of Excellence	N/A	2001-11-01	The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
NCT00039988 ↗	Treatment of Multiple Sclerosis With Copaxone and Albuterol	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2001-11-01	The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
NCT00078338 ↗	Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis	Completed	Pfizer	Phase 4	2004-02-16	The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

Clinical Trial Conditions for Copaxone

Condition Name

Condition Name for Copaxone
Intervention	Trials
Multiple Sclerosis	17
Relapsing Remitting Multiple Sclerosis	10
Relapsing-Remitting Multiple Sclerosis	7

Condition MeSH

Condition MeSH for Copaxone
Intervention	Trials
Sclerosis	42
Multiple Sclerosis	42
Multiple Sclerosis, Relapsing-Remitting	31

Clinical Trial Locations for Copaxone

Trials by Country

Trials by Country for Copaxone
Location	Trials
United States	289
Germany	31
Canada	23
Brazil	21
Italy	16

Trials by US State

Trials by US State for Copaxone
Location	Trials
California	17
New York	15
Ohio	13
Washington	11
Texas	11

Clinical Trial Progress for Copaxone

Clinical Trial Phase

Clinical Trial Phase for Copaxone
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	13
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Copaxone
Clinical Trial Phase	Trials
Completed	30
Unknown status	7
Terminated	7

Clinical Trial Sponsors for Copaxone

Sponsor Name

Sponsor Name for Copaxone
Sponsor	Trials
Teva Pharmaceutical Industries	15
Teva Branded Pharmaceutical Products R&D, Inc.	12
Teva Neuroscience, Inc.	4

Sponsor Type

Sponsor Type for Copaxone
Sponsor	Trials
Industry	57
Other	45
NIH	4

COPAXONE®: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to COPAXONE®

COPAXONE® (glatiramer acetate injection) is a widely used medication for the treatment of relapsing forms of multiple sclerosis (MS). It is an immunomodulator that modifies the immune processes believed to be responsible for the pathogenesis of MS.

How COPAXONE® Works

COPAXONE® acts by altering the immune system's response, which is abnormal in MS patients. This alteration helps in reducing the frequency of relapses and the progression of the disease. The central nervous system (CNS), comprising the brain, spinal cord, and optic nerves, is the primary area affected by MS, and COPAXONE® targets this system to mitigate the disease's impact[1].

Clinical Trials and Efficacy

Primary Study Results

Clinical trials have demonstrated the efficacy of COPAXONE® in reducing the number of relapses in patients with relapsing-remitting MS (RRMS). A pivotal trial involving 3-times-a-week administration of COPAXONE® 40 mg showed a significant reduction in relapses compared to placebo over a 12-month period. This reduction in relapses is crucial as relapses can cause new symptoms or worsen existing ones[1][4].

Secondary Study Results

In addition to reducing relapses, COPAXONE® has been shown to decrease the underlying disease activity as measured by brain lesions on magnetic resonance imaging (MRI). Studies have indicated a significant reduction in T1 and T2 lesions, which are indicators of disease activity, compared to placebo[1][4].

Long-Term Safety and Efficacy

A 27-year study of the active ingredient in COPAXONE® found long-term safety results. Participants in the clinical trial who opted into a long-term, open-label extension (OLE) study demonstrated sustained efficacy and safety over time. Early initiation of glatiramer acetate was associated with better outcomes, highlighting the importance of timely treatment[1].

Key Clinical Trials

Khan 2013 GALA Study

This 12-month, double-blind, placebo-controlled study involved patients with RRMS who were randomized to receive either COPAXONE® 40 mg/mL or placebo. The study showed that COPAXONE® significantly reduced the total number of confirmed relapses and the number of new or enlarging T2 lesions[4].

Comi 2009 PreCISe Study

This 3-year study focused on patients with clinically isolated syndrome (CIS), a precursor to MS. COPAXONE® 20 mg/mL administered once daily delayed the time to conversion to clinically definite MS and reduced the number of new T2 lesions[4].

Johnson 1995 Study

This double-blind, randomized, placebo-controlled trial in patients with RRMS demonstrated that COPAXONE® 20 mg/mL reduced relapses and disease activity as measured by MRI lesions[4].

Market Analysis and Projections

Global Multiple Sclerosis Drugs Market

The global multiple sclerosis drugs market is projected to grow significantly. According to forecasts, the market is expected to increase from $21.16 billion in 2024 to $38.94 billion by 2032, with a compound annual growth rate (CAGR) of 7.9% during the forecast period[2].

Market Drivers

Key factors driving this growth include new product launches, increasing government initiatives to improve care and treatment accessibility, rising prevalence of MS, and significant investments in research and development. The immunomodulators segment, which includes COPAXONE®, is set to lead the market by drug class[2].

Competitive Landscape

Top players in the MS drugs market include Biogen, F. Hoffman-La Roche Ltd., Novartis AG, and Sanofi. These companies are continuously innovating and expanding their product portfolios to address the evolving needs of MS patients[2].

Patient Compliance and New Formulations

Injectable vs. Oral Formulations

COPAXONE® is administered via injection, which can be a barrier to patient compliance. However, new pipeline products, including oral formulations like Aubagio and BG-12, and other injectable formulations with less frequent dosing (e.g., once a month or every six months), are expected to improve patient compliance and tolerance. These new drugs have shown superior efficacy in some clinical trials compared to currently approved products like COPAXONE®[3].

Conclusion

COPAXONE® has a well-documented clinical profile with demonstrated efficacy in reducing relapses and disease activity in MS patients. Its long-term safety and efficacy make it a valuable treatment option. As the global MS drugs market continues to grow, driven by new product launches and increasing demand, COPAXONE® remains a significant player, particularly in the immunomodulators segment.

Key Takeaways

• COPAXONE® is an immunomodulator that modifies immune processes to treat relapsing forms of MS.
• Clinical trials have shown COPAXONE® to significantly reduce relapses and disease activity.
• Long-term studies have confirmed the safety and efficacy of COPAXONE®.
• The global MS drugs market is projected to grow significantly, driven by new product launches and increasing demand.
• COPAXONE® is part of the leading immunomodulators segment in the MS market.

FAQs

What is COPAXONE® used for?

COPAXONE® is used to treat relapsing forms of multiple sclerosis (MS).

How does COPAXONE® work?

COPAXONE® works by modifying the immune processes believed to be responsible for the pathogenesis of MS.

What are the key findings from clinical trials of COPAXONE®?

Clinical trials have shown that COPAXONE® significantly reduces the number of relapses and disease activity as measured by MRI lesions.

What is the projected growth of the global MS drugs market?

The global MS drugs market is projected to grow from $21.16 billion in 2024 to $38.94 billion by 2032, with a CAGR of 7.9%.

Who are the top players in the MS drugs market?

Top players include Biogen, F. Hoffman-La Roche Ltd., Novartis AG, and Sanofi.

Are there new formulations that could replace COPAXONE®?

Yes, new pipeline products, including oral formulations and less frequently administered injectables, are being developed to improve patient compliance and efficacy.

Sources

1. Learn How COPAXONE® Works to Treat Relapsing MS. Copaxone.
2. Multiple Sclerosis Drugs Market | Competitive Landscape [2032]. Fortune Business Insights.
3. Multiple Sclerosis Therapies Market Size 2032. Allied Market Research.
4. Read the Efficacy Profile of COPAXONE®. Copaxone HCP.
5. Multiple Sclerosis Treatment Market and Forecast 2024-2031. iHealthcareAnalyst.